MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Inclusion Criteria: * Cytological or histological diagnosis of non small-cell lung cancer (NSCLC) * Stage III B or Stage IV disease * Age \> or = 70 years * ECOG Performance status 0 or 1 * Patient at first diagnosis or with recurrence after primary surgery * At least one target or non-target lesion according to RECIST criteria * Life expectancy of at least 3 months * Neutrophils \> 1500/mm3, platelets \> 100,000/mm3, hemoglobin \> 10g/dl * Creatinine \< 1.5 x the upper normal limit * AST and ALT \< 2.5 x the upper normal limits (\< 5 x the upper normal limit in the presence of hepatic metastasis) * Bilirubin \< 1.5 x the upper normal limit * Signed informed consent Exclusion Criteria: * Previous chemotherapy for advanced disease * History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * Symptomatic cerebral or spinal cord metastasis * Myocardial infarct within the last 12 months * Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy. * Known or suspected hypersensitivity to any of the drugs used in the study * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent